IFRA restrictions and EU regulations are NOT the same: some facts

In several threads and throughout fragrance fora and blogs there are several misconceptions about IFRA restrictions and the EU regulations. Especially the difference between the 2 doesn't seem to be clear.

Below I will try and explain those, to the best of my abilities. This information comes from the (brief) experience as an insider from the fragrance industry. For the last 2 years I have been involved in several tasks and worked closely with both perfumers, fragrance chemists, scientists and regulatory bodies. So I hope to shed a bit of light.

I always stand corrected if other insiders care to join in and give their point of view.

I will however do my best and keep facts and personal opinions separated.

Most important detail: ONLY companies that are a member need to abide by their safety restrictions. Truth is: most big companies are indeed a member.
However many indie perfumers are NOT a member.

~~~~~

EU stands for European Union. Within the 23 countries that are a member of the EU there is legislation for the manufacturing and selling of cosmetic products. Perfume is a cosmetic product. The legislation is called the EU cosmetics directive.

The word legislation says it all: this is a law, it is NOT a guideline for members only. ALL companies that are either located in the EU or sell to the EU MUST follow that law.

Shortly: for companies selling fragrance to or within the EU, the EU law must be followed, while IFRA restrictions are OPTIONAL = for members only.

Where do all these misunderstandings come from?

There is a BIG difference between the IFRA restrictions and the EU cosmetics directive.

IFRA describes many different safety levels of several fragrance ingredients. They also prohibit around 90 fragrance ingredients.

The EU cosmetics directive also currently known as 76/768/EEC prohibits less fragrance ingredients (around 30).

Since 1976 the EU cosmetics directive has undergone a few changes. One of them was known as the 7th Amendment to the Cosmetic Directive of the European Union (EU). In 2003 the directive has added 26 new ingredients to the “Annex III List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down."

With the exception of 4 fragrance ingredients that are restricted to certain levels, it only says that 26 fragrance materials have been identified as perfume allergens. Thus all 26 MUST be disclosed on the label of a cosmetic product, but ONLY if their quantity in the fragrance exceeds a certain level (for perfume that level is 0.001%). Click here and search for example 'fragrance' and see the exact materials.

For example oakmoss is one of those perfume ingredients. A perfume sold in the EU that contains 50% oakmoss, may be sold in the EU as long as 'oakmoss' is listed on the label as being 1 of the ingredients.

However in order to maintain uniformity IFRA also tightened their restrictions, although from the EU point of view, they didn't need to.

Before this piece of new legislation will become reality the EU consults with Scientific Committee on Consumer Safety = SCCS. In June 2012 this committee has entered a paper regarding the latest on dermatological research regarding possible fragrance allergens. Click here to read the original paper

In the official document the SCCS does offer several solutions for allergy suffers, prohibition being just 1 of the possibilities. However keep in mind that the SCCS is only an advisory body, it does NOT make the law.

This paper did raise concerns with the fragrance industry and attracted much media attention.
Therefor the EU released this official summary to the public:click here to read this summary

It looks like prohibition is off the table and the restrictions are only limited to disclosing more fragrance materials on the label, again only if their use exceeds a certain level.

Personal opinions/insights:

The EU legislation changes all the time. The economic climate dictates much of the outcomes. It seems too easy to blame the 'Brussels bureaucrats' for changes occurring in the fragrance industry. Much more is going on. Bad journalism is all about chasing sensational stories and stating things black and white in order to get attention. The practice differs, in my experience much is considered before law becomes reality.

And then there is always the fact that not everyone follows the law. And that there are differences in how each EU country puts the law into practice, including monitoring safety.

When more needs to be disclosed to the public, those fears will have a ripple effect. So how can a consumer actually comprehend the many layers of the truth if media is thriving on fear? And who knows who is actually feeding those fears to the media? And to what intent?

Also some manufacturers may see this as yet another opportunity to either cheapen a formula or prevent unnecessary future problems, for example out of fear of getting sued. Even if the IFRA nor the EU don't dictate those changes.

A friend of mine that is a journalist told me once: 'if you want to know the truth, follow the money or power'.
I believe that the truth lies somewhere in the middle between making a living and gathering more money or power. Meanwhile I tend to stick to the facts.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Thank you, Irina! This is very clearly stated. Unfortunately, I believe this is at the bottom of the changes we are seeing in so many beloved scents; "Also some manufacturers may see this as yet another opportunity to either cheapen a formula or prevent unnecessary future problems, for example out of fear of getting sued. Even if the IFRA nor the EU don't dictate those changes."

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Nicely laid out, Irina - thank you for pulling it together.

The telling item for me is that IFRA dropped the ball early on and actually over-compensated - more than required. This is the crux of the resentment of many of us, amply expressed by Turin in the recent 'Little Book', that rather than making a stand (Wasser was the only one to really speak out in public), they rolled over and, it would seem, used it as an excuse to reformulate either (a) using their own proprietary 'captives' or (b) just plain cheaper shit - in the hopes no-one would really notice that perfumes have gone from living, breathing entities to cheap synthetic one-liners. In that, they were right - smart move financially but the death of modern perfumery (late 18c circa Jicky - end of 20c) as some of us have known it.

The fact that the public is only now becoming aware of it - the whole 'no more Chanel No.5' thing - is about 10 years too late. The EU will steamroller on and the IFRA is not going to take a step backwards in time and re-open all the growers fields and orchards that have gone out of business.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Originally Posted by Irina

.......A friend of mine that is a journalist told me once: 'if you want to know the truth, follow the money or power'......

Your friend was right.

"Get your facts first, and then you can distort them as much as you please." It's a machine. It's growing all the time, and they're all part of it. In the meantime, people need to tell the fragrance firms what they want.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Thank you for the kind words, you're very welcome

Indeed there are many issues with how this works. My personal issue is for example that while being allergic to many of the 82 ingredients, it all depends on the concentration. The EU law doesn't protect me enough, I would rather have transparency (like with food 'it contains peanuts') than the whole threshold regulation.

What makes me sad is that perfumistas like here on BN are just such a minority that only small very niche indie companies would be inclined to listen, meaning that not much is going to change our way. For me it's one of the main reasons I personally got into perfume making.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

I agree with your friend 100 %, lovely thread!!

To me it all sounds like big companies want to keep the status quo, keep their market share, so nothing new may shine out if all will be forced to use synthetics, or aroma chemical companies are more powerful, or they share profits,but something about the money is definitely , and not about safety!:-)

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Wow! That was a great read and actually calmed me down a bit. I was very anti IFRA and EU regulations, but you put it into perspective beautifully. I'm sure the big companies are looking for the cheapest way to make a scent, but I'm thankful for those perfumers who are not.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

We have this rash of warnings on food products these days about the contents possibly contaminated by nuts (either in composite contents or by the machinery that made it). This way people with food allergies can be informed and make other decisions. This was the sensible thing to do. The insensible thing would have been to force food manufacturers to come up with synthetic nuts that don't cause allergies.

Applying this analogy to fragrances, makers should simply have the choice as to whether or not they want to use real oakmoss, clove, or whatever else the IFRA has glibly decided to ban. The consequence is that the outer packaging needs to have a warning. Yes, that makes the packaging less attractive, but cigarette manufacturers had to deal with it and it didn't negatively affect sales by much at all.

Of course, the IFRA does have a necessarily role. Without them there have been many natural resources exploited at will, wrecking the eco-system and allowing some plants to be pushed into extinction. And it is important to be aware of which ingredients used in perfumes may have a notable allergy risk for the population.

I'm of the opinion that the IFRA is operating much like a government agency, allowing themselves to be lobbied by various interests to make their decisions. Because the restrictions really do not harm the big houses--they're always investing in R&D, and being able to come up with something new that the competition doesn't have is yet another profit opportunity. Why not squash other houses dependent upon the real thing, forcing them to either rely on expensive substitutes or make an inferior facsimile?

Frankly, what I'd like to know is just how invasive the IFRA is. Do they have the clout to make surprise visits to perfume manufacturers and if a violation is found, make a damaging press release? Or is this all about the honor system?

Re: IFRA restrictions and EU regulations are NOT the same: some facts

The IFRA is a lobby group and acts as such.
Abiding by the IFRA Code of Practice is a prerequisite for all fragrance supplier companies that are members of the IFRA. Some non-members choose to comply with it nonetheless. Not doing so is "difficult to sustain in the EU because of the need for safety assessments and in the US because you are likely to be sued and defending the case when you have not abided by the internationally recognised safety standards is going to be very difficult to say the least", to quote Chris Bartlett.

Just inform people about potential contact allergens in fragrances with some kind of warning on the packaging?

According to the EU regulation on cosmetic products, "containers or packaging must bear written information" on all "ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing." Apparently EU legislation pushes for transparency of ingredients in consumer products. This, however, puts considerable pressure on the fragrance industry because there is no sufficient legal ground to claim intellectual property of a fragrance formula. The IFRA expressed this dilemma for instance in this article: "Products such as (...) fine fragrances all contain a fragrance formula" but "legally it is considered as ‘artisanal’ and therefore cannot be protected. Because of this, historically the fragrance industry has closely guarded the secrets of its formulae". So, the question at hand is, how can the fragrance industry satisfy the need for more ingredient information whilst protecting its formulae?
The IFRA would therefore like to have the EU incorporate trade secrets into its legislation on Intellectual Property, analogous to the US and Japan. It makes its case in favour of trade secrets in this paper from 2011. Meanwhile the Commission acknowledges that "there is sufficient economic justification for harmonization of trade secrets protection" in a recent study.
Furthermore (and already mentioned by Irina), it is required that 26 fragrance allergens must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products, e.g. perfumes, and 4 fragrance ingredients are restricted to certain levels. Whether or not this is grounded on up to date scientific research may be debatable (and is discussed in this article).
Your cigarette example, cytherian, has to do with elasticity of demand and unless you happen to know that demand for fragrances is inelastic, it is an inept comparison.

However, up until now EU legislation on cosmetic products is significantly less rigorous than the IFRA code when it comes to ingredients of concern. But this may change in the near future. In 2012, the SCCS (Scientific Committee on Consumer Safety), an independent advisory body to the Commission, produced a paper, "Opinion on fragrance allergens in cosmetic products", in which more than 100 additional individual substances and natural extracts have been identified as established or likely contact allergens. The SCCS also identified primary and secondary prevention measures, from prohibition to information, that could limit or eliminate exposure to fragrance allergens. For a brief overview on the paper, refer to the official summary.

It is yet not clear what legislation the Commission is going to come up with next year and whether or not the European Parliament and EU Council are going to pass it without any changes. I merely wonder if it would indeed be without any effect on the MEPs decision, if a significant number of fragrance connoisseurs from the EU were to get in touch with their representatives and voiced their stance. After all, one can surely assume that their interest is reelection amongst others and European Parliament election is scheduled for 2014.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Thanks for your post, Mia.

Due to the prevailing financial climate in much of Europe I suspect that even the most attention-seeking MEP here in the U.K. (mine is not one of those, fortunately) would be most reluctant to lobby on behalf of a market generally perceived to be concerned with frivolous luxury products.
The fact that other industries may be having similar problems is possibly another matter.

We're increasingly seeing food banks being used here & more people than usual are somewhat pre-occupied with the question of how to pay their fuel bills, so identification with this issue will probably be very low on the agenda.
Presumably, that is why the situation exists.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Very nice thread. Thanks Irina.

Very interesting question is how are the "natural perfumery" houses dealing with the restrictions. I mean if they want to stay natural they should not use synthetics, but if they stay natural they will have not many oils to choose from - no sandalwood, no oakmoss, etc. The restrictions seem very bad especially for this market. I find it ironic that because of the risk 1-3% of the population can receive allergic reaction all the rest 97-99% have to use synthetics which are even more harmful to the human body (of course only if you are not allergic) in the long term.

Are you aware which famous producers do not follow IFRA restrictions or EU regulations? Maybe those who are not based in Europe and don't have Europe as main market? Maybe the Middle East exclusive lines, etc.?

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Originally Posted by dessso

Very nice thread. Thanks Irina.

Very interesting question is how are the "natural perfumery" houses dealing with the restrictions. I mean if they want to stay natural they should not use synthetics, but if they stay natural they will have not many oils to choose from - no sandalwood, no oakmoss, etc. The restrictions seem very bad especially for this market. I find it ironic that because of the risk 1-3% of the population can receive allergic reaction all the rest 97-99% have to use synthetics which are even more harmful to the human body (of course only if you are not allergic) in the long term.

Welcome to Basenotes!
As a friendly suggestion, do go back and read Irina's excellent post again. She's also provided some very useful links that are worth taking a look at.
In response to a few points raised in your post:

1. All perfumes sold in the E.U. must comply with E.U. regulations; it's that simple. Restrictions cover both natural and synthetic ingredients.
2. So far as I know, sandalwood isn't restricted under E.U. regulations, nor is oakmoss (though the latter must be listed as an ingredient when present). It is the IFRA that suggests oakmoss be limited in its use. Adherence to IFRA standards is voluntary and some houses (mostly smaller ones) do not comply.
3. I think a blanket statement like "synthetics which are even more harmful to the human body (of course only if you are not allergic) in the long term" is wrong.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

In just 18 months time materials like Lyral will be required to be removed from perfumes in the EU. With this in mind I wondered to what extent this would:
1. Impact fragrances which are produced outside the EU but shipped to OR

2. Distributed within the EU zone.

3. If a fragrance is produced in the EU in 2017 and it contains Lyral, will this be prohibited from sale or as it was produced earlier will it be permissable for sale.

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Muguet odorants really have had a rough time of it: first hydroxycitronellal, now Lyral (Cyclohexal) as well as Lilial are on the chopping board.
Interesting to note Givaudan's response: https://www.givaudan.com/sustainabil...er-regulations. They seem to have been phasing out Lyral for some years, replacing it with their Mahonial.
Chemist Philip Kraft seems to be looking on the bright side:

And actually, we don't need to be afraid to miss Lyral/Cyclohexal and Lilial/Lyasmeral. This will lead to some differentiation as we saw it with musks when the omnipresent Galoxolide was dethroned in the 1990s

Re: IFRA restrictions and EU regulations are NOT the same: some facts

Originally Posted by gandhajala

Muguet odorants really have had a rough time of it: first hydroxycitronellal, now Lyral (Cyclohexal) as well as Lilial are on the chopping board.
Interesting to note Givaudan's response: https://www.givaudan.com/sustainabil...er-regulations. They seem to have been phasing out Lyral for some years, replacing it with their Mahonial.
Chemist Philip Kraft seems to be looking on the bright side:

And actually, we don't need to be afraid to miss Lyral/Cyclohexal and Lilial/Lyasmeral. This will lead to some differentiation as we saw it with musks when the omnipresent Galoxolide was dethroned in the 1990s

.

Awesome link - thanks for that!

MAHONIAL(TM) is a very interesting molecule, vis-a-vis its relationship to Lyral. And, as I've often discovered in this whole "industry molecules" thing, I had to do what seemed like an inordinate amount of digging around to find out what Mahonial actually is. The bottom line is that - not surprisingly - it's structurally similar to Lyral, but with what is presumably a very key difference. It's easier to show people than to explain, and there are many fascinating questions raised, so I'll work on that for a while and come back with a better post. Again, THANKS!